Study On The Influence Factors And Control Methods In The Process Of Magnification In Shuangshen Tongguan Capsule

Objective:Based on the preliminary work of the technology of ShuangshenTongguan Capsule,the magnifying process of Shuangshen Tongguan Capsule was studied to find out the obvious chemical composition caused by the process amplification,and to analyze the influencing factors causing the difference.Exploring process control methods to reduce the loss of composition and ensure the quality of the preparation.Method:HPLC method was used to determine the content of main ginsenosides,salvianolic acid and fascia alkaloids in Shuangshentongguan Capsules.The content of several main components in the extraction,separation,purification and drying process of the small and pilot test was determined,and the transfer rate of each component at each stage was calculated,the data differences was analyzed by ANOVA.Based on the statistic analysis,the influencing factors causing the differences were demonstrated further.According to the basic principles of degradation kinetics,the influencing factors were investigated and the degradation kinetics equation was calculated.Results:After the methodological investigation,several methods in the linear relationship,precision,stability,repeatability,and sample recovery rate met the relevant requirements,indicating that the established method is suitable for 3 ginsenosides and 12 salvianolic acids.Qualitative and quantitative analysis of two species of Corydalis alkaloids.The metastasis rate of ginsenoside Rbl,ginsenoside Re,ginsenoside Rgl,salvianolic acid B,tetrahydropalmatine,and dehydroproline was used as a reference index.Three of the six chemical components were expressed in the small test and the pilot test.Statistical differences were found(p<0.05).The transfer rate of ginsenoside Rbl in the two processes of concentration and refining was significantly higher than that of the small test.The transfer rate of salvianolic acid B in the pilot test process was significantly higher than that of the small test,but the drying process of the the transfer rate of the small test was higher than the pilot test process.The transfer rate is higher than that of the pilot test;the dry transfer rate of the tetrahydrofuran sample test is significantly higher than that of the pilot test.The stability study of salvianolic acid B in different eluates of Salvia miltiorrhiza showed that the other components in Salvia miltiorrhiza extract and its own concentration were also the influencing factors of salvianolic acid B stability.Some components of Salvia miltiorrhiza extract has a protective effect for salvianolic acid B.The degradation kinetics of tetrahydropalmatine and dehydrocortino were investigated.It was found that the degradation reaction of tetrahydropalmatine was basically consistent with the first-order reaction.Oxygen was the most critical factor that affecting the stability of tetrahydropalmatine.The stability of tetrahydropalmatine is better in the absence of oxygen.In addition,the temperature,solution pH and solvent have certain effects on the stability of tetrahydropalmatine.The lower temperature,the better stability of tetrahydropalmatine is better;in the neutral solution,the stability of tetrahydropalmatine is worse;with 50%ethanol as the solvent,the stability of tetrahydropalmatine is best.The degradation reaction of dehydroacetic acid basically conforms to the first-order reaction.The temperature,pH,solvent,oxygen,and other components in the extract of Corydalis have certain effects on the stability of dehydrocortin.The temperature is higher,the degradation of purine base of the dehydrogenation purple is faster;the stability of dehydrocortinin is better in the solution with neutral pH;the dehydrohydropurine is the most stable in the pure methanol solvent medium;under anaerobic conditions,the stability of dehydroproline is better than that under aerobic conditions;there are other components in the extract of Corydalis which can enhance the stability of dehydroacetin.Conclusion:During the process of magnifying of Shuangshen Tongguan Capsule,the factors which affect the chemical composition are temperature,oxygen and storage time.The process of amplification has the most significant effect on salvianolic acid B.It involves many aspects and various factors.In addition to temperature,pH,solvent,ionic strength,additives,etc.,other components in Salvia miltiorrhiza extract and its own concentration are also the influence factors which affect the stability of salvianolic acid B.The chemical constituents of Salvianolic acid A,caffeic acid,protocatechuic aldehyde and rosemary acid are considered to be beneficial to the stability of Salvianolic acid B.It was found that the higher the initial concentration of Salvianolic acid B,the more stable Salvianolic acid B was.Therefore,in order to control the quality of the drug and ensure the stability of salvianolic acid B,the temperature should be reduced and the heating time should be reduced while ensuring the extraction rate.In particular,the eluent should be mixed in time during the refining process.The eluent is concentrated and dried under reduced pressure to avoid the phenomenon that the degradation rate of salvianolic acid B is accelerated due to separation or low concentration between chemical components,and to reduce unnecessary loss.In the process of extraction,refining and drying,Corydalis should avoid to contact with oxygen as much as possible,especially pay attention to contact with oxygen at higher temperatures.In short,all the extracts and eluents of the medicinal materials should be treated in time,and the active ingredients should be in a relatively stable state as soon as possible.